摘要
目的优化盐酸吡格列酮格列美脲双层片的制备工艺。方法采用Plackett-Burman试验筛选关键工艺参数,找出关键因素,并以Box-Behnken响应面法优化,进行二次多元回归拟合,预测最佳制备工艺。结果黏合剂体积分数是影响自制双层片与原研制剂中盐酸吡格列酮溶出曲线相似因子的关键因素;格列美脲原料粒径与聚山梨酯80的用量是影响自制双层片与原研制剂中格列美脲溶出曲线相似因子的关键因素。利用响应面预测的最佳条件及最优处理效果为,格列美脲原料粒径d_(90)为5μm,黏合剂体积分数为3%,聚山梨酯80为每片2 mg,除格列美脲原料外,其他原辅料均过80目筛,流化床温度为40℃,压片机压力为9 kN,压片机转速为35 r/min。结论该方法用于盐酸吡格列酮格列美脲双层片的处方工艺优化,操作简便,预测性良好,试验结果符合要求。
Objective To optimize the preparation process of Pioglitazone Hydrochloride and Glimepiride Bilayer Tablets.Methods Plackett-Burman test was used to screen the critical process parameters(CPPs)of preparation of Pioglitazone Hydrochloride and Glimepiride Bilayer Tablets,and to investigate the significant influencing factors.Box-Behnken response surface method was used to optimize the CPPs,and to construct quadratic multiple regression to predict the optimal preparation process.Results The volume fraction of the binder was the most crucial factor affecting the similarity of the dissolution profile of pioglitazone hydrochloride between the homemade bilayer tablet and the original DUETACT.The particle size of glimepiride and the dosage of Tween 80 were the key factors that affected the similarity factors of the dissolution profile of pioglitazone hydrochloride in the homemade bilayer tablet and the original DUETACT.The optimal conditions predicted by the response surface method and their effects were as follows:the particle size(d_(90))of glimepiride was 5μm,the volume fraction of binder was 3%,Tween 80 was 2 mg per tablet,other raw materials and excipients except glimepiride were screened through 80 mesh sieve,the temperature of fluidized bed was 40℃,the pressure of tablet press was 9 k N,and the speed of tablet press was 35 r/min.Conclusion The method can be used to optimize the preparation process of Pioglitazone Hydrochloride and Glimepiride Bilayer Tablets,and it is simple and easy to operate and has a good prediction.The results of the test are in accordance with the requirements.
作者
杨鲁杰
司婕
卢来春
李志强
YANG Lujie;SI Jie;LU Laichun;LI Zhiqiang(Shandong Binzhouyoufu Hospital,Binzhou,Shandong,China 256600;Bioengineering College of Chongqing University,Chongqing,China 400044;Beijing Xiuzheng Innovative Pharmaceutical Research Institute Co.,Ltd.,Beijing,China 102206)
出处
《中国药业》
CAS
2021年第12期33-39,共7页
China Pharmaceuticals
关键词
质量源于设计理念
盐酸吡格列酮
格列美脲
双层片
制备工艺
优化
quality by design
pioglitazone hydrochloride
glimepiride
bilayer tablets
preparation process
optimization
